FDA Ruling to Regulate Electronic Nicotine Products Expected

FDA Ruling to Regulate Electronic Nicotine Products Expected

Dr. Graham Warren Photo courtesy of Julia Lynn

An anticipated ruling from the U.S. Food and Drug Administration (FDA) would give the agency authority to regulate electronic nicotine products. The lack of FDA authority over electronic nicotine products, combined with a lack of evidence that these products are effective tobacco cessation aids, has led ASCO to currently not endorse their use.

The FDA first proposed in 2014 a rule to extend its authority over all unregulated tobacco products, including electronic cigarettes (e-cigarettes), cigars, hookah tobacco, nicotine gels, and dissolvable nicotine products. Since then, ASCO and other organizations have called on the FDA to exercise its authority in regulating e-cigarettes and currently unregulated tobacco products.

Until the regulation is finalized and implemented, there is no federal oversight of these tobacco products. There are no restrictions in place to protect public health against the risks these products pose, particularly to the health of children.

In the absence of regulation, companies have employed irresponsible marketing of unregulated products such as cigars and e-cigarettes, using tactics and sweet flavors that appeal to youth. A recent Centers for Disease Control and Prevention report suggests that e-cigarette use by minors may be increasing more than anticipated.1

“The use of these products continues to evolve worldwide without a clear understanding of the clinical and biologic effects. Product design is changing on a rapid basis, but is a critical feature that will certainly govern the health effects both in people who are trying to use these to quit, as well as people interested in these products for social reasons, such as youth who may have never used tobacco,” said Graham Warren, MD, PhD, of the Medical University of South Carolina and chair of ASCO’s Tobacco Subcommittee. “As the evidence evolves, it is critical for ASCO, the American Association for Cancer Research, and other leading cancer organizations to assimilate information that can be used to help guide recommendations for clinicians and researchers, as well as to collectively advocate for regulation that will help clearly define evidence-base in the future.”

The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA immediate authority over cigarettes, as well as smokeless and roll-your-own tobacco. The act authorized the Secretary of the U.S Department of Health and Human Services to deem other tobacco products subject to the FDA’s jurisdiction.

ASCO and the American Association for Cancer Research (AACR) have published a policy statement on electronic nicotine delivery systems in Journal of Clinical Oncology and Clinical Cancer Research.2 The statement concluded that there are insufficient safety and efficacy data to recommend e-cigarettes as smoking cessation tools for the general population or for patients with cancer.

Key recommendations in the ASCO-AACR statement included: (1) additional research on e-cigarettes, including assessment of health impact, understanding patterns of use, and determining what role e-cigarettes have in tobacco smoking cessation; (2) product regulation at the federal, state, and local level to ensure appropriate reporting of product ingredients, childproof caps on liquids, and warning labels on products and their advertisements; (3) prohibition of child-friendly flavors; and (4) prohibiting e-cigarette use in places where tobacco smoking is prohibited.

The statement also recommends that doctors should encourage patients’ interest in quitting smoking, regardless of the patient’s approach; educate patients about FDA-approved therapies for tobacco dependence that are proven effective; and identify patients who truly have not had success with approved therapies during multiple quit attempts, who are adamantly unwilling to use them or who insist on e-cigarette use, and inform them of the currently limited state of knowledge about e-cigarettes. Physicians should emphasize to these patients that quitting tobacco smoking is their highest priority.

For the latest developments on e-cigarettes and tobacco cessation, visit ASCO.org.